Home-Based Photo-Biomodulation for Management of Lymphoedema and Radiation Fibrosis in Patients After Head and Neck Cancer: A Single-Arm Feasibility Trial

N/ANot Yet RecruitingNCT07139782

Peter MacCallum Cancer Centre, Australia30 enrolled

Overview

This feasibility trial will test the use of photo-biomodulation (PBM) therapy, predominantly self-delivered in the patient's home for 12-weeks, following completion of radiotherapy treatment for head and neck cancer. The primary objective is to establish feasibility of recruitment (uptake). Secondary objectives are to assess safety, additional elements of feasibility (adherence to the intervention, return of the device and attrition at the 3-month follow-up appointment) and acceptability of the trial to patients. Secondary measures will be performed to assess trends in effects of the intervention (pre-post intervention, within-group measures) for managing lymphoedema and radiation fibrosis.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

Riancorp: At the first intervention session the therapist will apply the device for 60 secs each at 14 - 25 points on the face and neck. Most patients will need application of the device at 15 to 20 points The Riancorp runs for 60 seconds, providing 1.5 j/cm2 in 60 seconds. Handycure: used by patients at home once/day on the prescribed days (Wks 1-6 3x/wk; Wks 7-10 x2/wk; Wks 11-12 x1/wk) 1. Patients will apply the device for 5 minutes at each point as instructed by the physiotherapist.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient has provided written informed consent using the HOME-PBM patient information and consent form 2. Patient is referred to the Lymphoedema Clinic for the management of head and neck lymphoedema and/or radiation fibrosis 3. Previously received curative-intent treatment (surgery and/or \[chemo\]radiotherapy) for mucosal head and neck cancer 4. Patient is able to attend appointments in person 5. Adults aged 18 years or older at Screening 6. Patient able to speak and read English Exclusion Criteria: 1. Patient has cognitive impairment that in the opinion of the Investigator would interfere with their ability to participate in the trial (e.g., complete outcome measures, perform the intervention) 2. Residual or recurrent disease within the head and neck 3. Has a diagnosis of photosensitive disorder (cutaneous porphyria, xeroderma pigmentosum, etc.) 4. Patient has tuberculosis or another form of virulent bacteria 5. Patient has a contraindication to receiving PBM treatment 6. Patient has no internet enabled device for telehealth video follow-up appointment

Outcomes

Primary Outcomes

Uptake (trial consent rate)

Consent rate and reasons for declining trial participation

Time frame: Throughout the trial for 12-months of recruitment

Secondary Outcomes

Adverse events

Safety will be measured by the number of adverse events (AEs) related to the trial intervention and outcome assessments and reported according to the Common Terminology Criteria for Adverse Events version 5.

Time frame: Throughout the trial for 12-months of recruitment

Acceptability

Assessed by inviting a subgroup of patients (n=15-20) to complete an individual semi-structured interview by telephone or videoconferencing.

Time frame: Three months post baseline

Program adherence

The number of scheduled clinic and telehealth sessions attended

Time frame: Throughout the trial for 12-months of recruitment and completion of 3-month follow-up

Program adherence

Adherence to prescribed unsupervised intervention (PBM) sessions

Time frame: Throughout the trial for 12-months of recruitment and completion of 3-month follow-up

Retention

Patient retention at the follow-up assessment

Time frame: 3-months post-baseline

Neck circumference

Neck circumference to be measured using the Assessment of Lymphoedema of the Head and Neck (ALOHA) method